Atopic DermatitisPhase 3NCT02601703
To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)
A Phase 3 study testing Tacrolimus Ointment 0.1% and Protopic® ointment, 0.1% in people with Atopic Dermatitis, run by Glenmark Pharmaceuticals Ltd. India at 60 sites in United States.
Trial summary
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Tacrolimus Ointment 0.1% and Protopic® ointment, 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,110 participants
- Where
- 60 sitesUnited States
- Study dates
- Aug 2015to Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD.
- Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka
- Have an IGA score of 3 (moderate) or 4 (severe).
- Have an affected Body Surface Area (BSA) of at least 20% at baseline.
- Treated with a bland emollient for at least 7 days.
Who cannot join
- Active cutaneous bacterial or viral infection in any treatment area at baseline.
- Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.
- History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
- History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
- Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Glenmark Investigational Site 31
Anaheim, California
Glenmark Investigational Site 60
Baytown, Texas
Glenmark Investigational Site 23
Bell Gardens, California
Glenmark Investigational Site 45
Brooksville, Florida
Glenmark Investigational Site 30
Cerritos, California
Glenmark Investigational Site 15
Chula Vista, California
Glenmark Investigational Site 53
Cincinnati, Ohio
Glenmark Investigational Site 21
Cleveland, Ohio
Glenmark Investigational Site 43
Coral Gables, Florida
Glenmark Investigational Site 34
Doral, Florida
Glenmark Investigational Site 22
Fort Lauderdale, Florida
Glenmark Investigational Site 3
Hazleton, Pennsylvania
Glenmark Investigational Site 41
Henderson, Nevada
Glenmark Investigational Site 35
Hialeah, Florida
Glenmark Investigational Site 59
Hialeah Gardens, Florida
Glenmark Investigational Site 9
High Point, North Carolina
Glenmark Investigational Site 27
Houston, Texas
Glenmark Investigational Site 39
Houston, Texas
Glenmark Investigational Site 8
Houston, Texas
Glenmark Investigational Site 14
La Mesa, California
Glenmark Investigational Site 24
Lampasas, Texas
Glenmark Investigational Site 16
Las Vegas, Nevada
Glenmark Investigational Site 1
Long Beach, California
Glenmark Investigational Site 52
Macon, Georgia
Glenmark Investigational Site12
Madisonville, Kentucky
Glenmark Investigational Site 11
Miami, Florida
Glenmark Investigational Site 19
Miami, Florida
Glenmark Investigational Site 33
Miami, Florida
Glenmark Investigational Site 40
Miami, Florida
Glenmark Investigational Site 42
Miami, Florida
Glenmark Investigational Site 50
Miami, Florida
Glenmark Investigational Site 51
Miami, Florida
Glenmark Investigational Site 54
Miami, Florida
Glenmark Investigational Site 56
Miami, Florida
Glenmark Investigational Site 58
Miami, Florida
Glenmark Investigational Site7
Miami, Florida
Glenmark Investigational Site 28
Miami Gardens, Florida
Glenmark Investigational Site 29
Miami Lakes, Florida
Glenmark Investigational Site 18
Miramar, Florida
Glenmark Investigational Site 37
Missouri City, Texas
Glenmark Investigational Site 6
Nashville, Tennessee
Glenmark Investigational Site 32
North Miami Beach, Florida
Glenmark Investigational Site 17
Oceanside, California
Glenmark Investigational Site 48
Orlando, Florida
Glenmark Investigational Site 4
Ormond Beach, Florida
Glenmark Investigational Site 25
Pasadena, California
Glenmark Investigational Site 47
Pembroke Pines, Florida
Glenmark Investigational Site 10
Pflugerville, Texas
Glenmark Investigational Site 2
Saint Joseph, Missouri
Glenmark Investigational Site 13
San Antonio, Texas
Glenmark Investigational Site 26
San Antonio, Texas
Glenmark Investigational Site 55
San Antonio, Texas
Glenmark Investigational Site 20
San Ramon, California
Glenmark Investigational Site 44
Santa Ana, California
Glenmark Investigational Site 38
Sugar Land, Texas
Glenmark Investigational Site 49
Tempe, Arizona
Glenmark Investigational Site 36
Toledo, Ohio
Glenmark Investigational Site 57
West Columbia, South Carolina
Glenmark Investigational Site 46
Wilmington, North Carolina
Glenmark Investigational Site 5
Winter Park, Florida
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (Tacrolimus) Ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD)
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).
- Conditions
- Atopic Dermatitis
- Being tested
- Tacrolimus Ointment 0.1%, Protopic® ointment, 0.1%, Placebo of Tacrolimus Ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus Ointment 0.1%Drug
apply thin layer of ointment to affected area
Protopic® ointment, 0.1%Drug
apply thin layer of ointment to affected area
Placebo of Tacrolimus OintmentDrug
apply thin layer of ointment to affected area
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus Ointment 0.1% | Experimental | Not described Receives: Drug: Tacrolimus Ointment 0.1% |
| Protopic® ointment, 0.1% | Active comparator | Not described Receives: Drug: Protopic® ointment, 0.1% |
| Placebo of Tacrolimus Ointment | Placebo comparator | Not described Receives: Drug: Placebo of Tacrolimus Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
Measured: Day 15
Secondary outcomes (1)
The change in severity score from baseline to study Day 15 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Nikhil Sawant, Study director, Glenmark Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601703
- Sponsor's protocol ID
- GLK-1501
- Status last verified
- Jul 2019
- First submitted
- 9 Nov 2015
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (Tacrolimus) Ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT02601703
- Acronym / sponsor ID
- GLK-1501
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus Ointment 0.1% | Experimental | Drug: Tacrolimus Ointment 0.1% |
| Protopic® ointment, 0.1% | Active comparator | Drug: Protopic® ointment, 0.1% |
| Placebo of Tacrolimus Ointment | Placebo comparator | Drug: Placebo of Tacrolimus Ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD.
- Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka
- Have an IGA score of 3 (moderate) or 4 (severe).
- Have an affected Body Surface Area (BSA) of at least 20% at baseline.
- Treated with a bland emollient for at least 7 days.
Key exclusion criteria (5 listed)
- Active cutaneous bacterial or viral infection in any treatment area at baseline.
- Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.
- History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
- History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
- Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus Ointment 0.1%apply thin layer of ointment to affected area | Drug | Tacrolimus Ointment 0.1% |
| Protopic® ointment, 0.1%apply thin layer of ointment to affected area | Drug | Protopic® ointment, 0.1% |
| Placebo of Tacrolimus Ointmentapply thin layer of ointment to affected area | Drug | Placebo of Tacrolimus Ointment |
Primary outcome
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
Time frame: Day 15
1 secondary outcome
The change in severity score from baseline to study Day 15 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).
Time frame: Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nikhil Sawant study director
Glenmark Pharmaceuticals Ltd
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus Ointment 0.1% and Protopic® ointment, 0.1% in people with Atopic Dermatitis, run by Glenmark Pharmaceuticals Ltd. India at 60 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.